The letters and numbers in the following are referred to in the application form. When applying for an extension to a previously authorized study, use the usual e-mail: vsn@vsn.is

Note that a special application should not be sent to the Data Protection Authority. The processing of personal data is covered in Chapter B of the application.

Generally, the application is based on Icelandic. However, an application may be submitted in English if the instructor, co-investigators or the population to which the study is aimed is English-speaking. If this is the case, item 3 must also be in Icelandic. Note that all data to participants must be in Icelandic.

1. Full name of the study in Icelandic. Foreign name may be included in brackets.

2. Type of research. There is active participation by individuals (i.e. a scientific study in humans) or a data study (i.e. without active participation by individuals).

3. Describe in chronological terms the objective of the study, the implementation, the participants/population and the scientific value of the study. This section shall be in Icelandic.

4. Investigators appoint from among their own group one responsible person who is responsible for all communication with VSN and is professionally responsible for the conduct of the investigation. He is also responsible for all data of the investigation and processing it. The student is never the responsible person for his own investigation and shall work under the guidance of the responsible person.

5. Co-investigators. Please identify everyone who is responsible for the aspects of conducting the study (name, workplace/school, title, e-mail and telephone). Identify students.

6. Collaborating parties. Please identify all institutions, schools and companies, domestic or foreign, involved in the study. Please identify the sponsors and the kind of support or grant they provide. Information on the type of support is sought.

7. The division of tasks between investigators. Please specify who is responsible for the supervision of the individual tasks.

8. Information shall be provided on interests, financial, financial, employment etc. that could affect the conduct or outcome of the investigation. The financing of the investigation shall be explained.

Health data is defined as health information and biopsies. This includes information from medical records, and data from biopsy collections and health information collections and other information on the medical history and health status, as well as information provided by participants, e.g. in response to questionnaires or by undergoing tests. Medical records are defined in the Act on Medical Records: "A description or interpretation in written language, images, including X-rays, graphs and video and audio recordings containing information concerning the health of the patient and his treatment by a healthcare professional or a healthcare institution and other necessary personal information." Other information on the medical history and health status may include information on genetic characteristics and drug, alcohol and drug use. Information may also be provided by the Directorate of Health, Icelandic Health Insurance, the Social Insurance Administration, residential and nursing homes, the Prison and Probation Administration of Iceland. Health information also includes information obtained through a study of a biopsy. A biopsy is defined as a biological material from human beings, living or dead, which can provide biological information. If biopsies from biopsy collections are used in a data study, it is assumed that the biopsies will be returned to the relevant collection.

1. Collection. Please specify with which variables will be processed, (such as age, gender, measurement results and diagnosis). Non-personal data shall be processed equally. Please specify all data sets, including medical records, biometric datasets, health information collections, to which data will be retrieved. What other data will be collected – where and how. If information is obtained directly from participants, please specify how such collection will be conducted.

The SCRC reaffirms that the Committee’s authorization to record interviews in research is limited to the use of a recording equipment – not the investigator’s mobile phone – and that the authorization does not include a permission to record a photograph, unless specifically mentioned.

2. Encryption. If an analytical or encryption key is created, the security issues and the storage period of the key must be clarified. If investigators receive data in a personal identifiable form, the date when it will be made non-personal identifiable will be stated.

3. If you have a processing of genetic information, describe the processing, who is responsible for it and how the data will be transferred between the processor and the investigators.

4. Processing of personal data. Will contracts be entered into for the processing of personal data in the name and on the responsibility of investigators? If so, the processing shall be explained, who will handle it and how security will be protected

5. Who will have access to the research data? How will their security be protected (access control, preservation and encryption)? Where and how will data be stored during the research? Will identifiable data be deleted and when, i.e. the analytical or encryption key?

• Health data obtained for data research may be permanently stored in a bio-sample collection and a health information collection authorized by the Minister, provided this is provided for in a research plan approved by the national bioethics committee or the ethical committee for health research.

• If a person does not wish to have health data concerning him/her used in data research, he/she must make his/her wish known by prohibiting in the medical record that data from him/her are used in scientific research.

• Health data of individuals who have not prohibited their use in data research may be used and then stored in a health information/bio-sample collection, provided personal data protection is protected and the ethics committee is approved.

• If bio-sample collections are used for data research, it is assumed that the bio-sample will be returned to the relevant collection.

• The preservation of health data obtained for a scientific study in humans or resulting from its implementation is subject to the approval granted for the study.

• If health data has been collected in a limited scientific study in humans and the participant has not been given consent for retention for use in future studies according to Article 17, it shall not be stored for longer than is necessary for the conduct of the study.

• However, the ethics committee may decide after the final results have been received by the committee that the necessary health data should be retained for a period necessary for the evaluation of the study. After that period, the data shall be deleted or made non-identifiable, unless they are required to be retained by law. The preservation of health data obtained for human pharmaceutical research or resulting from its implementation is governed by the laws and regulations on pharmaceuticals.

6. If data belonging to a study is intended to be transferred from Iceland, it must be stated what data is involved, for what purpose, in what form, to which institution and country the data will be transferred, how the security of the data will be protected, what processing is carried out by the recipient, and which employee of the recipient will be given temporary possession of the data and be responsible for it. Furthermore, it must be stated whether it is planned to transfer unused biopsies back to Iceland or delete them abroad and how this would be done. Information is requested on an agreement with the recipient of the data, a signed declaration of cooperation or other legal basis for the transfer of data from Iceland.

7. Sharing and co-running. Is it planned to share information or samples from other studies? If yes – please state their names, VSN numbers and the names of the responsible parties. The responsible party's authorization is required for the sharing of data from other studies and such use of the data must be within the consent granted by the participants. Will records be shared for the purpose of a study? These could be records stored by public bodies, hospitals, the Directorate of Health, the birth registry, the medical record, accident records, unemployment, etc.

8. Informed consent. This indicates whether informed consent will be sought for participation. If so, refer to section D of the application. The consent of participants does not apply in the case of data research.

1. Research methods. Methodology and description of the conduct of the study, what methods and data will be used and how. What kind of processing (e.g. statistical) was done in preparation for the study. What is expected of the participants, including where they are to be, what kind of samples will be taken, whether and how often participants are to be there for monitoring, evaluation or sampling.

2. Ethical considerations are relevant to all research. They include the validity of conducting a study, selection of samples, risks and benefits for the participants, trust and payments to them, the relationship between researchers and sponsors, the relationship between researchers and participants, whether participants belong to vulnerable groups (including children, pregnant women, elderly, mentally disabled, retarded, prisoners). It is especially important to address measures taken to protect vulnerable groups if appropriate. It is also important to consider that research on vulnerable groups can be a part of improving services for them.

3. Benefits of the study. It is necessary to explain what scientific benefits are expected from the study and what practical results are expected from the study, e.g. direct effects on the treatment and health of the participants.

4. Theoretical background of the study. Describe the status of knowledge in the field and the theoretical background, including the main results of previous studies on which the study is based. It is important to discuss this point as it is a scientific justification for conducting this study.

5. Investigation period. Please state when the investigation is scheduled to begin and when it is expected to be completed. Please note that investigations may not be initiated before the Scientific Ethics Committee's authorization is available and that the authorization expires when the date of the investigation's completion has passed.

6. Presentation of the results of the study. The general rule of VSN is that the results of studies shall be published. The obligation lies with the responsible person to publish all the results of a study regardless of its outcome and whether the results confirm the researcher's theory of work or not. Rejecting a hypothesis can be as important scientifically as confirming it. Explain the intended use, publication and presentation of the results of a study.

(Not applicable unless communication is made with individuals in the study sample).

1. Participants. How will participants be recruited and who will contact them? Please state the age, gender and number of participants if possible, how and on what grounds the sample will be selected.

2. Type of approval. The participation in a scientific study in humans must be obtained by means of written consent. It must be stated whether a limited approval will be sought limited to one study or a broad approval allowing the use of biopsies and health information in other studies for which the Scientific Ethics Committee would be asked for permission. The preservation of the research data must be in accordance with the consent granted by the participant. If a limited approval is used, the research data must not be stored for longer than necessary and must be deleted after the study.

3. Acquisition of consent. How and who obtains informed consent? For the participation of a non-voluntary individual, the consent of the guardian or parent is required. The answer to a questionnaire is equivalent to written consent.

4. Risks/benefits of participation. Please state what the potential risks and benefits of participation are.

5. Supporting party for participants. If there is a risk of emotional distress following participation, e.g. in interviews, participants are requested to have the opportunity to discuss once, free of charge, with a professional body independent of the investigation. A written declaration of cooperation is requested. If the investigator/student is of little experience, the committee will always request that the investigator's representative or another member of the investigators' group be with the student during the first interviews.

6. Supervision and insurance. Who is responsible for monitoring the health and well-being of the participants during the study and how will this be carried out? Are the participants insured against possible harm due to their participation in the study? In the case of insurance, the participant must be informed of what the insurance cover entails. The Scientology Ethics Committee requires insurance “without charge” and that the participant can seek legal action in Icelandic courts.

7. Payments for participation. Are participants reimbursed for travel expenses incurred in connection with participating in the study? Do participants receive rewards for participating? If so, please indicate the nature and amount of the payments for participation. It is permissible to reward participants with normal rewards. However, the rewards or amount must not be such as to distort the person's assessment when deciding to participate in the study. The rewards must therefore be proportionate. The ethics committee must be satisfied that all payments and rewards to participants are in accordance with the stress and discomfort involved in participating but are not in such a way as to encourage participants to take more risks than they would have taken otherwise. Refunds for expenses incurred or rewards for job losses are not considered as an attempt to have an abnormal effect on participants, provided that there are no amounts that represent a significant part of the income or sole income of the person participating in the study.

8. The obligation of controllers to disclose information, see Article 19 (2) of Act No. 44/2014. How participants who give their express consent will be informed about the research being conducted by the controller, institution or company. According to Article 19 (2) of the Act on Scientific Research in the Health Sector, participants who have given their express consent have the right to be informed about the research in which their health data is used. The research plan of a scientific study must state how the controller intends to meet this obligation, for example, by sharing information on his website. This is intended to strengthen the rights of participants who have given their express consent so that they can monitor how data from them is possibly used and thus have the possibility to reject the use of their data in the proposed research.

The liability of the controller.

By submitting this application to the national bioethics committee, the responsible person confirms that the research plan will be strictly followed, all permits related to the research will be attached to the application and that all employees have undergone a confidentiality procedure. The research may not be started until all permits have been obtained.

The responsible person is responsible for all the data of the investigation and all the processing with it. Any proposed changes from the approved investigation plan must be sent to the responsible person for consideration by the committee.

Scientific studies in humans are not permitted unless there is informed consent. However, in emergency situations where the patient cannot give consent and it is not possible to obtain the consent of the closest family member, a study that is not part of the treatment is permitted subject to certain conditions. Click here to read more about informed consent.

If you want to advertise for participants in a study, e.g. in newspapers, institutions, in pharmacies or online, a copy of the advertisement must accompany the application to the ethics committee.

The following points shall be included in the advertisement:

• Letterhead/Sign of the organisation to which the investigation relates

• Title and content of the study in a few words

• Research field

• Who is invited to participate

• Investigation controller, title, location

• Who to contact for further information

• Whether participation is paid for

• That those who contact investigators are merely expressing interest in further information but not committing to participation

In the document below are examples and instructions on what should be included in the presentation material for participants in a scientific study in the health field. Researchers can use the material at their own discretion and adapt it to the study to be sent to VSN.

It is important to conduct research on different groups. Needs are different and diseases or other pathogens affect people in different ways. The laws on such research and all international conventions on bioethics in research emphasise special care when it comes to individuals or groups that are vulnerable.

Examples of vulnerable individuals and groups are children, senior citizens, women with disabilities, mourners, prisoners, victims of violence, those for whom the legal guardian has been appointed due to illness or disability and the unconscious. Special care is required when the study is done on any of the above groups.

Click here to read more about vulnerable groups.

The student is never the responsible person for his own study but works on it under the guidance of the responsible person. The responsible person for the study applies to the national bioethics committee (VSN) or the institution's ethics committee.

Division of duties by ethics committees

Applications shall be evaluated by the Ethics Committee of LSH or the FSA if the instructor is an employee of the institution and the study is entirely carried out within or under the auspices of the FSA or LSH with data stored there. The VSN evaluates an application if:

• the study is a collaboration between two or more institutions, regardless of whether they have their own ethics committees

• The participants are recruited from outside the institution where the instructor works (LSH, FSA)

• The study is multinational with participation of one or more participants in Iceland

• The project is a clinical pharmacology study

Delivering learning projects

• A. New assignments: Applications must be submitted to the relevant ethics committee. Students should be considered as co-investigators.

• B. Additions to older projects approved by the VSN or the institution’s ethics committee: An application for an addition shall be submitted and reference to the number and authorisation for the original study.

The relevant ethics committee will discuss any changes to approved projects, including new employees/co-investigators (e.g. students) and their role in the project. To ensure that applications are discussed and permitted in time, it is important that they are received by the ethics committee as soon as possible. Applications are processed in the order in which they are received. A completed and signed application must be accompanied by the required permits and authorisations/notifications. Student research projects are discussed in a manner comparable to other scientific research on humans and the same conditions are used as the basis for permitting. There is reason to reaffirm that the application submitted for discussion is well-resourced. It should be reaffirmed that VSN's permit to record interviews in research is limited to the use of a sound recording equipment - not the investigator's mobile phone - and that the authorisation does not include a permit for the recording of a photograph, unless specifically mentioned.

When answering a questionnaire, whether a list that participants answer and post or answer online, a signed consent form shall not be requested, as it is considered that answering a questionnaire is the equivalent of consent.

In case of an urgent question on sensitive issues, a sensitive population or if the applicant is in doubt, please contact the Secretariat of the Ethics Committee, e.g. the national bioethics committee.

In questionnaire, caution should be exercised when using open questions or answering options. The option "Other" is acceptable without further detail.

When respondents are minors, it is necessary to ensure that the parent/guardian can view a questionnaire to be able to take a decision on whether an adolescent should be allowed to answer.

In the promotional material, it must be stated how long it takes to answer the questionnaire.

If it is necessary to state the age of the participants, it is the general rule that it is stated in age ranges and not in years of age.

Postal checks

In general, the following methodology is accepted in such surveys:

• A briefing letter/electronic mail sent at the beginning of the study to those who were included in the sample

• A questionnaire or password to the questionnaire website sent by letter or e-mail

• Replay sent to those who do not respond a week later

• A new questionnaire will be sent out with a replay to those who do not respond at least two weeks later

• A thank you letter sent after the investigation/data collection is completed, if deemed appropriate – only applicable to mail survey.

Online surveys

A survey is presented, for example, through advertisements or e-mail to defined groups. Those who are interested in participating contact the investigators and are sent a password to a site where the questions can be found. No personal identifiable information shall be requested or given in such surveys.

If further information about a participant is obtained, for example from a medical record, the participant must sign an informed consent.

Medical records: Written descriptions or interpretations, images, including X-rays, graphs and video and audio recordings that contain information about the patient's health and treatment at the healthcare professional/healthcare institution and other necessary personal information.

A medical record is a collection of medical records that are processed in connection with treatment or obtained from elsewhere for the treatment of a patient in a healthcare institution or a healthcare professional's office.

The medical records must include items necessary for treatment, but at least the following information, where appropriate:

• Name of the patient, address, ID number, title, marital status and next of kin.

• Date of arrival or admission and date of graduation. Reason for arrival or admission.

• The health and medical history that are important for the treatment.

• Warnings, such as about allergies.

• Inspection. Treatment and procedure description, including information on medication and comments from advisory experts.

• Results of research.

• Analysis. The fate and schedule of follow-up treatment.

Health records controller: The senior management of the healthcare institution or healthcare professionals' office where the health records are recorded.

The health register administrator: A doctor, or another healthcare professional, if not a doctor, who is assigned by the administrator to supervise and ensure that the registration and handling of the health register information is in accordance with the provisions of law.

Each entry of medical records information in the medical record shall include the name of the person who records, his/her title and the timing of the entry. Any addition, correction, change or deletion made to the medical record entry shall always be traceable.

The Icelandic Health Records Act no. 55/2009 defines such records, the responsibility for their entry and use.

Biopsies collected from participants in a scientific study:

1. The collection of biological samples from participants in a scientific study is the responsibility of the national body, the scientist or the physician of the participant concerned (for example, for the initial presentation to the prospective participant) responsible for the implementation of the project. According to law (No. 110/2000) biological samples obtained for certain research (and not intended for preservation in a biological sample collection) may be retained for up to 5 years. VSN may exempt from this rule, i.e., allow temporary preservation for longer than 5 years.

2. The responsibility for all aspects of conducting a study, including the handling of biological samples and other data, lies with the responsible person. In the case of international cooperation, the responsible person for the part of the study that is conducted in Iceland shall be responsible for all aspects of the study here, including obtaining authorization from the parties required.

3. Participants must be informed of how biopsies will be taken and for what purpose, how they will be treated and whether or how they will be preserved. The same applies to any information relating to the samples.

4. If the intention is to send biological samples to other countries and the consent of the participants is required. The participants must be informed of any examinations to be carried out on the samples externally, where and for how long the samples will be kept abroad. This does not apply when the need to obtain informed consent from the participants (non-personalised samples) is not necessary.

5. Biopsies may only be sent abroad for certain research aspects, which have been defined in the research plan and approved by VSN. Biopsies should also be informed about this research aspect and have given their consent for sending samples and accompanying information out of the country. A responsible person for the possession and destruction of samples abroad or return to Iceland must be appointed.

6. Biopsies may only be sent out of the country in non-personal form. The national investigator can store a coded list of participants and is responsible for its secure custody. Such a key may under no circumstances be sent out of the country.

7. It is not permitted to send samples out of the country beyond the amount required for the research factors specified in the research plan. The remaining samples shall be returned after the study has been completed. If this is not possible, the investigator in Iceland is responsible for destroying the samples or their remaining parts at the end of the study. This process shall be defined in the research plan.

8. The movement of biological samples for permanent storage abroad is subject to the VSN permit. In general, no permit will be granted to date unless it is clear that the rights and interests of Icelandic biological sample donors are strictly protected, and in the same way their samples would be stored in Icelandic biological sample collections.

Samples obtained from Icelandic biopsy collections:

1. The use of bio samples obtained from Icelandic bio sample collections shall be in accordance with Act No. 110/2000 on Bio sample banks and Regulation No. 134/2001 on the possession and use of bio samples in bio sample collections.

2. The movement of samples from Icelandic biological sample collections is subject to the VSN permit and the rules/ criteria described above also apply in such cases.

3. It is noted that the deceased donors may include individuals who have withdrawn their intended consent for their samples taken for service or treatment to be stored in a biopsy collection for use in scientific research. In this case, biopsies from these individuals may of course not be used.

Applications for authorization for epidemiological studies (data studies) must be submitted to VSN or the Ethical Committee of Health Research according to Article 11 of Act No. 44/2014. A general study form must be used.

“epidemiology is the study of distribution and the effects of a condition or a phenomenon of health in a particular population. It also deals with the exploitation of the research to control health problems.

Epidemiologists are concerned with research on the spread and causes of disease in human populations. The main subject of the research is the relationship between exposure and outcome.

The effects of stimuli can be diverse. Most often they are associated with increased risk of getting sick from a particular disease and are called risk factors. Examples of these are smoking, carcinogens in food, pollution related to employment, high blood pressure, viral infections and inborn mutations in disease genes. The effects of other stimuli are to reduce the likelihood of certain diseases. This category includes food reduction agents, breastfeeding, vaccination and education about the harm of smoking. The endpoints of the studies are usually diseases but can also include accidents, deaths, antibodies in the serum, certain risk behavior and more.

Since the subject of the research is human beings, there is a fundamental difference between the research and any other method of investigating the causes of disease. It is both a strength and a weakness of the research that the subject of the research is human beings. The strength is that there is no doubt that the results can be transferred to living people, whereas there is usually no doubt about results based on animal experiments or on tissue, cells or smaller units.”

(Source: The University of Iceland’s Website.)